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Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors

Primary Purpose

Leukemia, Lymphoma, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone counselling
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone Counselling

Control

Arm Description

Participants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention.

Participants will be asked to increase their exercise by at least 60 minutes per week and will be self-directed, only receiving a copy of Canada's Physical Activity Guideline as standard of care.

Outcomes

Primary Outcome Measures

Change from baseline in Exercise Levels
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire

Secondary Outcome Measures

Change from baseline in Exercise Motivation
Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework
Change from baseline in Quality of life
Quality of life assessed using the Short Form-36 (SF-36) questionnaire
Change from baseline in Fatigue
Fatigue assessed using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) questionnaire

Full Information

First Posted
January 31, 2017
Last Updated
October 2, 2017
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03052777
Brief Title
Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Behavior, Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Counselling
Arm Type
Experimental
Arm Description
Participants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be asked to increase their exercise by at least 60 minutes per week and will be self-directed, only receiving a copy of Canada's Physical Activity Guideline as standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Telephone counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Exercise Levels
Description
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire
Time Frame
Baseline and within 7 days of completing the 12-week intervention
Secondary Outcome Measure Information:
Title
Change from baseline in Exercise Motivation
Description
Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework
Time Frame
Baseline and within 7 days of completing the 12-week intervention
Title
Change from baseline in Quality of life
Description
Quality of life assessed using the Short Form-36 (SF-36) questionnaire
Time Frame
Baseline and within 7 days of completing the 12-week intervention
Title
Change from baseline in Fatigue
Description
Fatigue assessed using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) questionnaire
Time Frame
Baseline and within 7 days of completing the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
t6g 2h9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30501541
Citation
Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Social Cognitive Effects and Mediators of a Pilot Telephone Counseling Intervention to Increase Aerobic Exercise in Hematologic Cancer Survivors. J Phys Act Health. 2019 Jan 1;16(1):43-51. doi: 10.1123/jpah.2018-0014. Epub 2018 Dec 2.
Results Reference
derived
PubMed Identifier
29411314
Citation
Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Feasibility and preliminary efficacy of an exercise telephone counseling intervention for hematologic cancer survivors: a phase II randomized controlled trial. J Cancer Surviv. 2018 Jun;12(3):357-370. doi: 10.1007/s11764-018-0675-y. Epub 2018 Feb 6.
Results Reference
derived

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Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors

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