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Feasibility of Health Coaching in Cancer Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556528
Recruitment Status : Unknown
Verified September 2015 by Emma Sparkes, Oxford University Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Emma Sparkes, Oxford University Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE September 17, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date September 22, 2015
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
Feasibility of health coaching intervention in cancer patients within the NHS [ Time Frame: up to 4months (depending on length of each cycle of treatment). Patients will be seen at up to 4 concetutive clinic visits. ]
To assess whether a 10 minute semi standardised health coaching session can be conducted with NHS cancer patients by pharmacists trained in health coaching and to gather the opinions of the patients and the health coaches as to whether the intervention is of benefit and warrants further investigation. Measures of feasibility include: Recruitment figures, logistics of conducting health coaching sessions, review of the recorded coaching sessions, attendance rates, qualitative analysis of reflection notes and end of study interview with patients, Patient activation measure at baseline and end of study.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Health Coaching in Cancer Patients
Official Title  ICMJE A Study to Assess the Feasibility of Using Health Coaching Sessions in Cancer Patients
Brief Summary

This is a study to assess the feasibility of using health coaching sessions in cancer patients. The investigators are investigating whether health coaching sessions can be delivered to this group of participants in a semi structured way. The investigators hope that the study will allow us to see whether such sessions can be delivered in a timely manner that is acceptable to patients and staff. The longer term aim for this work, should it prove feasible, is to conduct a randomised controlled trial to assess health coaching.

The participants for the study will be selected using purposive sampling. The investigators will select a sample of 10 patients. The participants will be patients at the Oxford University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will include male and female patients and try to cover a range of ages from 18 upwards. It will cover patients taking a range of oral anticancer agents, for a range of different cancer indications. The sample will look at patients who are newly prescribed oral anticancer therapy through to patients who have been taking therapy for years.

Participants will be identified for the study by multidisciplinary staff members who are running oral education sessions or by non-medical prescribers who are seeing patients in clinic. These members of the MDT will be given lists of the types of participants the investigators are looking for in the study and where appropriate offer patients the opportunity to take part. Patients will be contacted prior to the end of their subsequent cycle of treatment about whether they wish to participate. Patients wishing to take part will be consented at their next clinic visit.

All participants will attend for their usual clinic visits throughout the study. Participants will additionally be offered up to 3 health coaching sessions for a maximum of three cycles or until treatment with their oral anticancer agent ends, whichever comes first.

At the end of study visit participants will be asked to attend a qualitative based interview to discuss the intervention.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Health Coaching
Study Arms  ICMJE Experimental: Health Coaching
Intervention: Behavioral: Health Coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 18, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is willing and able to comply with the protocol for the duration of the study.
  • Patient is willing and able to give written (signed and dated) informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with cancer.
  • Patient prescribed an oral anticancer agent.

Exclusion Criteria:

  • Patients who are unable to complete 1 cycle of oral anticancer therapy from the time of being approached about the trial.
  • Patients who would be unable to participate in a health coaching session with a health coach for any reasons, including, difficulty understanding or speaking English, other communication difficulties or hearing problems.
  • Other psychological, social or medical condition, that the Investigator considers would make the patient a poor trial candidate, could interfere with protocol compliance, could affect the patient's ability to give informed consent or may affect the interpretation of trial results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556528
Other Study ID Numbers  ICMJE PID: 11437
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emma Sparkes, Oxford University Hospitals NHS Trust
Study Sponsor  ICMJE Oxford University Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oxford University Hospitals NHS Trust
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP