Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05409638 |
| Other study ID # |
603412-190799-2001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
February 17, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Ottawa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cancer related fatigue (CRF) has been defined as a "distressing, persistent, subjective sense
of tiredness or exhaustion related to cancer or cancer treatment that is not proportional to
recent activity and interferes with usual functioning". CRF has been found to affect between
59-99% of patients undergoing active treatment. Approximately a third of cancer survivors
will continue to experience moderate to severe fatigue upwards of 10 years post-diagnosis.
Given the prominence of CRF, guidelines for the assessment and management of CRF have been
developed, including guidelines by the Canadian Association for Psychosocial Oncology (CAPO).
Despite the availability of guidelines for CRF and a plethora of interventions that have
demonstrated effectiveness in aiding patients manage CRF, implementation has been lacking.
The objective of this study is to adapt, implement, and evaluate an already existing
intervention for CRF in the community using the Knowledge-to-Action framework. This study is
an implementation study and evaluation of an evidence-based cognitive-behavioral therapy
intervention for CRF in a community setting. An evident knowledge to practice gap exists for
CRF management in Ottawa, Canada. Through partnership with a community organization, the
Ottawa Regional Cancer Foundation, and an emphasis on long-term sustainability, this project
aims to provide more accessible treatment for cancer survivors who are experiencing CRF in
the Ottawa region.
Description:
This study is a single center, hybrid II effectiveness-implementation pilot study. For the
effectiveness trial, the investigators will use a randomized controlled trial with a waitlist
control group. For the implementation portion of the study, the investigators will conduct a
process evaluation using the RE-AIM framework. Three groups of 10-15 cancer survivors will
take part in CrF intervention. Three groups were selected with consultation of the Ottawa
Regional Cancer Foundation as it currently offers groups three times a year in the fall,
winter, and spring/summer. Another three groups of approximately 10 cancer survivors will be
allocated to a 3-month wait-list control group after which they will be offered the CrF
intervention. Participants will be recruited through several methods: online advertisements,
informational letters and posters sent to community and healthcare organizations and key
healthcare providers (i.e., family physicians and health psychologists).
Effectiveness Component:
Participation will consist of attending 90-minute virtual groups for 4 consecutive weeks on
cancer-related fatigue. During the 4 weeks, participants will be asked to participate in
activities, participate in group discussions, and complete homework. They will also be asked
to complete a questionnaire package before the start of the intervention, one week after the
intervention is completed (5 weeks), and at 3-months post intervention. The questionnaires
package will include the following questionnaires. The primary outcome will be the
Multidimensional Fatigue Inventory (MFI-20). Secondary outcomes will be the Functional
Assessment of Chronic Illness Therapy (FACIT-F), PROMIS Self-Efficacy for Managing Chronic
Conditions-Short Form, Godin Leisure-Time Exercise Questionnaire, The Insomnia Severity
Index, and the Hospital Anxiety and Depression Scale (HADS). After the completion of the
intervention, they will also be asked to fill out a satisfaction survey once at 5 weeks where
they can provide feedback on their experience of the intervention, a component of the process
evaluation (see the next section for more detail). All surveys should take approximately 30
minutes. The waitlist control group, participation will consist of completing a 30- minute
questionnaire package at the start of the study, after 5 weeks and at a 3-month follow-up.
The same questionnaire package will be administered that the intervention group receives with
the exception of the satisfaction survey. After three months, participants will be offered
the chance to receive the intervention for cancer-related fatigue. They will only be asked to
complete the satisfaction survey where they can provide feedback on your experience of the
intervention and have the option to participate in the focus group should they wish too.
However, they will not be asked to re-complete the questionnaire packages they completed
during their wait time. Block randomization with a 1:1 ratio will be completed through an
online software. The following sociodemographic data will be collected: age, gender, marital
status, education, work class, ethnicity, cancer diagnosis, medication, other chronic
illness, history of insomnia and/or depression, smoking, location, income, and comfort with
technology.
Implementation component:
This process evaluation will follow a RE-AIM framework. For reach, the investigators will
document the number of individuals interested in the intervention and referral sources
through the patient demographic form. During past focus groups, the investigators discovered
a break-down in communication between community partner, patients, and healthcare
organizations. To increase reach and improve this gap, the investigators have several
strategies including online advertisements, knowledge dissemination through informational
letters to key providers (i.e., family doctors, health psychologists), and offering
presenting to community organizations and healthcare organizations. Additionally, feasibility
will be assessed retrospectively to examine whether the program was a success or failure,
specifically in regard to recruitment, retention, and participation rates. Recruitment
numbers and referrals, retention (i.e., percentage of individuals who complete the program),
and participation rates (i.e., attendance) will all be tracked throughout the project. If
possible, participants will be contacted and asked for the reason of discontinuing the
program. For effectiveness, the randomized control trial described above will be conducted.
For adoption, the investigators will interview key stakeholders at the Ottawa Regional Cancer
Foundation about the barriers and facilitators in maintaining this intervention long-term.
The investigators will also be accessing acceptability of the intervention through the
evaluation tool created by the Ottawa Regional Cancer Foundation. Evaluation Measure Designed
by the Ottawa Regional Cancer Foundation: Currently, programs at the Ottawa Regional Cancer
Foundation are routinely evaluated with an evaluation tool. The questionnaire is composed of
open-ended questions (e.g., how could the program be improved?) and Likert scales questions
on satisfaction (e.g., I would recommend this coaching program to others) and perceived
knowledge/skills gained (e.g., this program helped me develop strategies to better cope with
life). Further, focus groups (N=3) with 6-10 cancer survivors each who have completed the
intervention will be held to gain greater insight into their perspectives of the intervention
and which aspects were the most and least beneficial after each group. To assess the quality
of training the staff member received, an individual interview will be conducted to ascertain
the staff members' confidence and level of preparedness in providing the intervention. In
addition, the staff member will be asked about their perspectives of the program and whether
they recommend any changes. As the evaluator will be providing the training, the staff
interview will be conducted by another graduate student to reduce desirability bias and to
ensure the group facilitator can express their honest opinions. For implementation, the
investigators will conduct approximate intervention cost-tracking by determining the number
of hours the community partner puts into the intervention (i.e., training and facilitating
the intervention). Additionally, the intervention will be video recorded, and a fidelity
checklist will be completed to ensure high consistency of the intervention. Lastly, for
maintenance will be document whether the program is planned to be offered regularly after the
investigators have completed our research study
