Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors

Lymphoma Clinical Trial

Official title:

Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention—Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052777
• Other study ID #: HREBA.CC-16-0775
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: October 2, 2017
• Start date: February 21, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: October 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.

Description:

Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting intentions to exercise, though we are now discovering that only about half of those who intend to exercise actually follow through on their intentions. This is known as the exercise intention-behavior gap. It also appears that survivors are more likely to follow-through on their intention to exercise when they report employing key behavioral and motivational strategies (i.e., creating detailed exercise plans, feeling capable and obligated to exercise, perceiving it to be beneficial and fun, and avoiding the temptation to participate in alternative activities) which may be promoted via telephone counselling.

Objective: To determine whether a theory-based telephone counselling intervention focused on closing the exercise intention-behavior gap is feasible and can improve exercise levels, motivation, quality of life, and fatigue in hematologic cancer survivors.

Methods: A two-armed randomized controlled trial will compare the efficacy of telephone counselling versus a control condition (self-directed with Canada's Physical Activity Guide). All participants will be asked to increase their exercise by at least 60 minutes per week. Hematologic cancer survivors who previously participated in an exercise survey study and indicated interest in participating in future exercise related research (N=407) will be contacted to participate in the current trial. Eligible participants will be randomized in a 1:1 ratio to either the telephone counseling group or a self-directed exercise group. Participants in the intervention arm will receive 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. A sample of approximately N=66 hematologic cancer survivors will be recruited for this 12-week trial. Data will be collected via online surveys assessing changes in exercise levels, motivation, quality of life, and fatigue. Feasibility will be determined by eligibility percentage, recruitment percentage, adherence rate, assessment completion rate, adverse events, and ratings of program acceptability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria for this study will be survivors who have had a histologically confirmed hematologic cancer, and who are between 18-80 years of age, living in Alberta, can speak and comprehend English, and willing to participate in a 12-week exercise telephone counseling intervention.

Exclusion Criteria:

• Survivors reporting greater or equal to 150 minutes of moderate-to-vigorous exercise will be excluded because they will already be meeting the public health guidelines for exercise. Survivors planning to be away for more than 2 weeks during the intervention, or with major exercise contraindications will also be excluded.

Related Conditions & MeSH terms

• Behavior, Health
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Behavioral:
• Telephone counselling
The intervention is a 12 week telephone counselling exercise program where participants will receive weekly telephone counselling that targets key theoretical behavior change constructs. Participants will also receive a copy of Canada's Physical Activity Guideline.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Exercise Levels	Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire	Baseline and within 7 days of completing the 12-week intervention
Secondary	Change from baseline in Exercise Motivation	Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework	Baseline and within 7 days of completing the 12-week intervention
Secondary	Change from baseline in Quality of life	Quality of life assessed using the Short Form-36 (SF-36) questionnaire	Baseline and within 7 days of completing the 12-week intervention
Secondary	Change from baseline in Fatigue	Fatigue assessed using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) questionnaire	Baseline and within 7 days of completing the 12-week intervention