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CancerNCT05409638

Why am I Still Tired ? A Group for Cancer-related Fatigue

A study testing Cognitive Behavioral Therapy to manage cancer-related fatigue in people with Cancer and Fatigue, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Fatigue, CBT
What is being tested?
Cognitive Behavioral Therapy to manage cancer-related fatigue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
1 Jan 2022to 17 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 and over
  • Has received a cancer diagnosis
  • Has completed cancer treatment,
  • Self-reports experiencing fatigue,
  • Fluent in English.

Who cannot join

  • Currently in treatment
  • Has a diagnosis of brain cancer and is experiencing cognitive difficulties

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Ottawa

    Ottawa, Ontario, K1N6N5

Other trials in Canada

About this study

Official title: Why am I Still Tired? Adaption, Implementation, and Evaluation of an Intervention for Cancer-Related Fatigue.

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.

Read the detailed 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

Conditions
Cancer, Fatigue, CBT
Being tested
Cognitive Behavioral Therapy to manage cancer-related fatigue
Medical subject headings
Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy to manage cancer-related fatigueBehavioural

    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.

Study groups in NCT05409638
Study groupRoleWhat they receive
CBT intervention for cancer-related fatigueExperimentalParticipants will receive 4 weekly sessions consisting of psycho-education around fatigue, pacing, journaling fatigue, relaxation training, CBT, and evidence-based tips to increase physical activity.
Receives: Behavioral: Cognitive Behavioral Therapy to manage cancer-related fatigue
Wait-list control groupNo interventionParticipants assigned to this arm wait about 3-months to receive the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in baseline fatigue at one month

    Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores indicating greater fatigue

    Measured: Changes in fatigue at 1 month after the completion of the intervention

  2. Changes in baseline fatigue at three months

    Multidimensional Fatigue Inventory (MFI-20), range from 20 to 100 with higher scores

    Measured: Changes in fatigue at 3 month after the completion of the intervention

Secondary outcomes (11)
  1. Changes in baseline fatigue at 1 month

    Functional Assessment of Chronic Illness Therapy (FACIT-F) with a score range 0-52 with higher scores indicating better quality of life and less fatigue

    Measured: Changes in fatigue at 1 month after the completion of the intervention

  2. Changes in baseline fatigue at 3 months month

    Functional Assessment of Chronic Illness Therapy (FACIT-F) with a score range 0-52 with higher scores indicating better quality of life and less fatigue

    Measured: Changes in fatigue at 3 month after the completion of the intervention

  3. Changes in baseline physical activity at 1 month

    Godin Leisure-Time Exercise with a score range from 0 to 119 with higher scores indicating greater physical activity

    Measured: Changes in physical activity at 1 month after the completion of the intervention

  4. Changes in baseline physical activity at 3 months

    Godin Leisure-Time Exercise with a score range from 0 to 119 with higher scores indicating greater physical activity

    Measured: Changes in physical activity at 3 month after the completion of the intervention

  5. Changes in baseline depression and anxiety at 1 month

    Hospital Anxiety and Depression Scale Depression and anxiety (HADS) measure with a range from 0 to 42 with greater scores indicating more distress

    Measured: Changes in depression and anxiety 1 month after the completion of the intervention

  6. Changes in baseline depression and anxiety at 3 months

    Hospital Anxiety and Depression Scale Depression and anxiety (HADS) measure with a range from 0 to 42 with greater scores indicating more distress

    Measured: Changes in depression and anxiety 3 months after the completion of the intervention

  7. Changes in baseline insomnia at 1 month

    Insomnia Severity Index with a score range from 0-28 with higher scores indicating greater insomnia

    Measured: Changes in insomnia at 1 month after the completion of the intervention

  8. Changes in baseline insomnia at 3 month

    Insomnia Severity Index with a score range from 0-28 with higher scores indicating greater insomnia

    Measured: Changes in insomnia at 3 months after the completion of the intervention

  9. Changes in baseline self-efficacy at 1 month

    PROMIS Self-Efficacy for Managing Chronic Conditions with a score ranging from 0-10 with higher scores indicating greater self-efficacy

    Measured: Changes in self-efficacy at 1 month after the completion of the intervention

  10. Changes in baseline self-efficacy at 3 months

    PROMIS Self-Efficacy for Managing Chronic Conditions with a score ranging from 0-10 with higher scores indicating greater self-efficacy

    Measured: Changes in self-efficacy at 3 months after the completion of the intervention

  11. Satisfaction with the intervention

    Evaluation Measure Designed by the Ottawa Regional Cancer Foundation with score range from 19 to 95 with higher scores indicating greater satisfaction with the intervention

    Measured: One time, 1 month after completing the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Feb 2023
  4. Study completion17 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409638
Sponsor's protocol ID
603412-190799-2001
Status last verified
May 2023
First submitted
6 May 2022
Last updated
18 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy to manage cancer-related fatigue in people with Cancer and Fatigue, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in baseline fatigue at one month (time frame: Changes in fatigue at 1 month after the completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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