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A Psychosocial Intervention for Patients With Colorectal Cancer and Their Family Caregivers (iCanManage)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159363
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
National University Hospital, Singapore
Singapore General Hospital
Information provided by (Responsible Party):
HE Hong-Gu, National University, Singapore

Brief Summary:
This study aims to develop a smartphone-based psychosocial intervention for patients with colorectal cancer and their family caregivers and to improve patients' confidence in self-care, psychological well-being, social support, quality of life, and satisfaction with care, as well as caregivers' burden, psychological well-being, and quality of life. The study also aims to explore patients' and their caregivers' perceptions of the intervention and routine care. A multi-centre two-arm experimental study design is used in this study. A total of 100 patient-caregiver dyads will be recruited and randomly allocated to either the control group (receiving routine care alone) or the intervention group (receiving routine care plus the psychosocial intervention). After completed the study, 15 patient-caregiver dyads will be invited for interviews to explore their perceptions on the intervention and/or routine care. This study will generate evidence on the effectiveness of the easily accessible and sustainable smartphone-based psychosocial intervention.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage) Not Applicable

Detailed Description:
  1. Aims The aims of the study are: (1) To develop an interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage program); (2) To examine the effectiveness of iCanManage for colorectal cancer patients and their caregivers in improving patients' health outcomes including self-efficacy (primary outcome), psychological well-being (anxiety & depression), social support, health-related quality of life (HRQoL) and satisfaction with care, as well as caregivers' burden, psychological well-being, and quality of life (QoL) (primary outcome); and (3) To explore patients' and their caregivers' perceptions of iCanManage and routine care.
  2. Hypotheses Over 3 months' follow-up, compared to patients in the control group,patients who receive iCanManage in addition to hospital routine care will report significantly: (1) higher levels of self-efficacy, social support, HRQoL and satisfaction with care, and (2) lower levels of anxiety and depression; whilst caregivers will report significantly lower levels of burden, anxiety and depression, and higher level of QoL.
  3. Methodology A multi-centre two-arm randomised controlled trial will be conducted at two public hospitals in Singapore. A total of 100 patient-caregiver dyads will be recruited via convenience sampling. Participants (patient-caregiver dyads) will be randomly allocated to either the intervention (receiving iCanManage in addition to hospital routine care) or the control group (receiving only hospital routine care). The aforementioned outcomes of both patients and caregivers will be measured at baseline (start of access to iCanManage), 2-weeks post-surgery (end of access to iCanManage) and 3-months post-surgery. Descriptive statistics, repeated measures analysis of covariance, univariate analysis of covariance (ANCOVA) will be used to analyse the data. At the end of the trial, semi-structured interviews will be conducted to explore 30 patients' and 30 caregivers' perceptions on iCanManage and or routine care. The transcribed interview data will be analysed using a thematic analysis.
  4. Significance of the study This study will generate evidence on the effectiveness of the easily accessible and sustainable iCanManage. Should the quantitative and qualitative findings support the feasibility and effects of the intervention, it can be adopted by hospital policymakers as added routine care to enhance patients' self-management ability throughout their surgery journey.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Effectiveness of an Interactive Colorectal Cancer Self-Management Enhancement Smartphone-based Psychosocial Intervention Programme (iCanManage) on Outcomes of Patients With Colorectal Cancer and Their Family Caregivers
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Participants in the intervention group will receive an interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage) in addition to routine care provided by the respective hospitals.
Other: An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
The iCanManage consists of two components: (1a) Existing functions from the BuddyCare mobile application that provide a comprehensive 29 day-by-day perioperative guide for patients who will be undergoing colorectal elective surgery; (1b) a dashboard for healthcare professionals to monitor patients and their caregivers' well-being as well as allow mutual communication; and (2) Newly developed digitalised psychosocial content (e.g., mindfulness-based activities with audio cover, video materials related to positive psychology, patient ambassadors' success stories and relevant psychoeducation) tailored for colorectal cancer patients and caregivers, with the aim of providing them emotional and psychosocial support.

No Intervention: Control group
Participants in the control group will receive routine care provided by the respective hospitals . The routine care includes normal consultation with their attending physician, information concerning treatment plans, such as surgical procedures and its associated risks, preoperative preparations and postoperative care, treatment after discharge and/or subsequent adjunct therapy if required.



Primary Outcome Measures :
  1. Colorectal cancer patients' self-efficacy [ Time Frame: Patients' self-efficacy will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    The level of patient's self-efficacy will be measured by the 10-item General Self-Efficacy Scale (GSE). The General Self-Efficacy (GSE) Scale is a 4-point Likert scale (1 = not at all true, 2 = hardly true, 3 = moderately true, 4 = exactly true). The sum score ranges between 10 and 40 with a higher score indicating more self-efficacy.

  2. Caregivers' quality of life [ Time Frame: Caregivers' quality of life will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Caregivers' quality of life will be measured by 35-item Caregiver Quality of Life Index Cancer (CQOLC). Each item is scored from 0 (not at all) to 4 (very much). The total possible score is 140, with higher scores representing better quality of life.


Secondary Outcome Measures :
  1. Patients' anxiety and depression [ Time Frame: will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Patients' anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression scale (HADS). The Hospital Anxiety and Depression Scale comprises of 14-item self-report scale, 7 items for anxiety and 7 for depression. Each item on the HADS was scored on a four point (0-3) so the possible scores ranged from 0-21 for anxiety and 0-21 for depression. The scores of 8-10 in each scale may be suggestive of borderline risk of anxiety or depression and 11 or higher were indicative of probable 'caseness' of anxiety or depression (Pritchard, 2011; Snaith, 2003).

  2. Patients' Social support [ Time Frame: Patients' social support will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    The level of patients social support will be measured by the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS). The Medical Outcomes Study Social Support Survey (MOS - SSS) measures four aspects of social support including (1) tangible support; (2) affectionate support; (3) positive social interaction and (4) emotional-informational support (Shebourne & Stewart, 1991; Wang, Zheng, He, & Thompson, 2013). Without regarding the source of support, the frequency of support available to each participant was captured through response indications from none-of-the-time (= 1) to all-of-the-time (= 5) on a 5-point scale. Tabulated scores for each dimension are then rescaled to a 0 to 100 range, where higher scores indicate higher support availability (McDowell, 2006).

  3. Patients' Health-related quality of life [ Time Frame: Patients' health-related quality of life will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Patients' health-related quality of life will be measured by the 29-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Colorectal cancer specific (EORTC QLQ-CR29). The EORTC QLQ-CR29 has 29 questions comprises of four functional scales and 18 symptoms scales. All the items are scored on a four-point Likert scale (1-4). Raw scores will be linearly transformed to a scale scores ranging from 0 to100 according to EORTC scoring manual (Fayers et al., 2001). A high scale score for functional scale represents a better functioning, while a high score for a symptom scale represents a worse symptom.

  4. Patients' Satisfaction with care [ Time Frame: Patients' satisfaction with care will be assessed at baseline (around 2 weeks before surgery) ,and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Patients' satisfaction with care will be measured by the 1-item 6-point Ordinal Descriptive Scale (ODS) from 1 (very dissatisfied) to 6 (very satisfied).

  5. Caregivers' burden [ Time Frame: Caregivers' burden will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Caregivers' burden will be measured by the 21-item Caregiver Reaction Assessment (CRA). The CRA contains subscales of self-esteem, family support, finances, schedule, and health. Each item is scored on a five-point Likert scale, ranging from strongly disagree (score 1) to strongly agree (score 5). The items constituting a particular subscale are averaged to generate subscale scores (ranging from 1 to 5). A higher score on the self-esteem subscale indicates a more positive effect of caregiving, higher scores on the other subscales indicate greater negative effects of caregiving in those domains.

  6. Caregivers' anxiety and depression [ Time Frame: Caregivers' anxiety and depression will be assessed at baseline (around 2 weeks before surgery) and assessing changes between baseline and around 2 weeks after the surgery and 3 months after the surgery. ]
    Caregivers' anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression Scale (HADS). HADS comprises of 14-item self-report scale, 7 items for anxiety and 7 for depression. Each item on the HADS was scored on a four point (0-3) so the possible scores ranged from 0-21 for anxiety and 0-21 for depression. The scores of 8-10 in each scale may be suggestive of borderline risk of anxiety or depression and 11 or higher were indicative of probable 'caseness' of anxiety or depression (Pritchard, 2011; Snaith, 2003).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria for patients are:

    1. Aged 21 years old and above;
    2. Diagnosed with primary colorectal cancer;
    3. Scheduled for elective colorectal surgeries;
    4. Able to read and speak English and/or Mandarin;
    5. Have a smartphone with internet access; and
    6. Have one identifiable main family caregiver

The inclusion criteria for caregivers include:

  1. Aged 21 years old and above;
  2. Main family caregiver of the patient
  3. Able to read and speak English and/or Mandarin; and
  4. Have a smartphone with internet access

Exclusion Criteria for both patients and caregivers:

  1. visual or hearing impairments; and/or
  2. cognitive impairments/mental disorders identified in their medical record

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159363


Contacts
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Contact: Hong-Gu HE, PhD +6565167448 nurhhg@nus.edu.sg

Sponsors and Collaborators
Singapore Cancer Society
National University Hospital, Singapore
Singapore General Hospital
Investigators
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Principal Investigator: Hong-Gu HE, PhD National University, Singapore
Additional Information:
Publications:
Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: Freeman.
Bazaliński, D., Salacinska, I., Wiech, P. & Kozka, M. (2014). Life satisfaction and self-efficacy in patients with stoma. Progress in Health Sciences, 4(2), 22-30.
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.
Carlson, L., & Speca, M. (2011). Mindfulness-Based Cancer Recovery: A step-by-step MBSR Approach to help you cope with treatment & reclaim your life. Oakland, CA: New Harbinger Publications.
Chenail, R. J. (2011). How to conduct clinical qualitative research on the patient's experience. Qualitative Report, 16(4), 1173-1190.
Kabat‐Zinn, J. (2003), Mindfulness‐Based Interventions in Context: Past, Present, and Future. Clinical Psychology: Science and Practice, 10: 144-156. doi:10.1093/clipsy.bpg016
Kaynar, G. O. & Vural, F. (2018). Assessment of the caregiver burden of caregivers of colorectal cancer patients. Turkish Journal of Colorectal Disease, 28, 164-171. DOI: 10.4274/tjcd.26121
Liao, C. & Qin, Y. (2014). Factors associated with stoma quality of life among stoma patients. International Journal of Nursing Sciences, 1(2), 196 - 201. https://doi.org/10.1016/j.ijnss.2014.05.007
Lim, S. H. (2017). Developing and testing the preliminary effects of stoma psychosocial intervention programme on outcomes of colorectal cancer patients with stoma: a mixed methods study. PhD thesis. Singapore: National University of Singapore.
Loi, T. T. C. (2016). Developing and testing the effects of a psychoeducation intervention on patients with colorectal cancer: a mixed method study. PhD thesis, Singapore: National University of Singapore.
Machin, D., Campbell, M., Fayers, P., & Pinol, A. (1997). Sample size tables for clinical studies (2nd ed.). Oxford: Blackwell Science.

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Responsible Party: HE Hong-Gu, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT04159363    
Other Study ID Numbers: SCS2018
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will only be available for researchers involved in this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HE Hong-Gu, National University, Singapore:
psychosocial intervention
smartphone-based
patient
colorectal cancer
caregiver
randomised controlled trial
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases