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

NCT05409638 | Completed

• 1 other identifier: 603412-190799-2001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Fatigue; CBT

Outcome Measures

Primary Outcomes (2)

• Changes in baseline fatigue at one month

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

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

• Changes in baseline fatigue at three months

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

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

Secondary Outcomes (11)

• Changes in baseline fatigue at 1 month

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

• Changes in baseline fatigue at 3 months month

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

• Changes in baseline physical activity at 1 month

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

• Changes in baseline physical activity at 3 months

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

• Changes in baseline depression and anxiety at 1 month

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

Study Arms (2)

CBT intervention for cancer-related fatigue

EXPERIMENTAL

Participants 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.

Behavioral: Cognitive Behavioral Therapy to manage cancer-related fatigue

Wait-list control group

NO INTERVENTION

Participants assigned to this arm wait about 3-months to receive the intervention.

Interventions

Cognitive Behavioral Therapy to manage cancer-related fatigue BEHAVIORAL

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.

CBT intervention for cancer-related fatigue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Lebel, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 8, 2022
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 17, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)