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Trial record 20 of 575 for:    colon cancer | ( Map: California, United States )

Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers (Mindfulness)

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ClinicalTrials.gov Identifier: NCT02423720
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a audio based mindfulness meditation intervention for colorectal cancer patients and caregivers. A 8-week single arm study will be conducted among University of California, San Francisco (UCSF) patients with metastatic colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants total).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Audio-Based Mindfulness Not Applicable

Detailed Description:
A metastatic cancer diagnosis is associated with high levels of distress in both patients and caregivers. The investigators hypothesize that an audio-based mindfulness intervention will be an effective means to reduce distress and improve quality of life among patients with advanced cancer and their caregivers. With the Being Present study, conduct an 8-week single arm study among UCSF patients with metastatic colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants total). Participants will receive an informational booklet containing a practice log and a MP3 player containing an introductory lecture and guided meditations. Practice reminders will be sent via text messages. Emails will contain practice assignments and links to validated survey instruments. The survey instruments (National Comprehensive Cancer Network (NCCN) Distress Thermometer and National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) adult short forms) will measure global health, anxiety, depression, fatigue, and sleep quality before, during, and after the intervention to obtain preliminary estimates of the efficacy of the intervention among patients and caregivers on self-reported outcomes. Qualitative data will be collected from pre- and post-intervention interviews.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Being Present: Audio-Based Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
Actual Study Start Date : April 28, 2015
Actual Primary Completion Date : May 3, 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study Intervention
Audio-based mindfulness intervention A 8-week single arm pilot study will be conducted among Helen Diller Famiily Comprehensive Cancer Center (HDFCCC) patients with metastatic colorectal cancer receiving chemotherapy and their caregivers (44 participants, total). Participants will receive an informational booklet containing a practice log and an MP3 player containing an introductory lecture and guided meditations. Practice reminders will be sent via text messages. Weekly emails will contain practice instructions and links to validated questionnaires.
Behavioral: Audio-Based Mindfulness
Audio-based mindfulness tracks (MP3 format).




Primary Outcome Measures :
  1. Proportion of eligible patients and caregivers who agree to be screened, consent to participate, and complete or partially complete the intervention, as a measure of feasibility and acceptability. [ Time Frame: 8 weeks ]
  2. Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Reasons for ineligibility, as a measure of feasibility [ Time Frame: 8 weeks ]
  2. Proportion of enrolled patients and caregivers who refuse to participate in or complete the intervention, as a measure of feasibility and acceptability [ Time Frame: 8 weeks ]
  3. Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability [ Time Frame: 8 weeks ]
  4. Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages) [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Quality of life, as assessed by NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]
  2. Distress, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]
  3. Anxiety, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]
  4. Depression, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]
  5. Fatigue, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]
  6. Sleep quality, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study [ Time Frame: 0, 4 and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Eligible patients must:

  • Carry a diagnosis of metastatic colon, rectum, or small bowel adenocarcinoma
  • Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
  • Have life expectancy of at least 6 months
  • Have Karnofsky Performance Status ≥60
  • Be able to speak and read English
  • Have access to a mobile phone
  • Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
  • Have a distress level of ≥3 on the NCCN Distress Thermometer (DT).[1, 40]
  • An effort will always be made to recruit patient and caregiver pairs, but unpaired patients are also eligible

Eligible caregivers are a spouse/partner, other family member, or a close friend of a patient with metastatic colon, rectum, or small bowel adenocarcinoma.

Eligible caregivers must:

  • Be able to speak and read English
  • Have access to a mobile phone
  • Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

Exclusion Criteria:

This study is limited the study to patients with metastatic colon, rectum, or small bowel adenocarcinoma, because treatment regimens and disease trajectories for these disease groups are similar.

Deafness, Current meditation practice (>2 episodes or >1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because the study is designed as an audio-based introduction to mindfulness meditation.

Patients with a DT level >7 will be considered on a case-by- case basis. Patients and caregivers who participate in a focus group and meet criteria for the intervention will be given the opportunity to participate: data will be collected, but these patients/participants will not be included in the final analyses so as not to bias the results.


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): NCT02423720


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Chloe Atreya, MD, PhD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02423720     History of Changes
Other Study ID Numbers: 15455
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases