NCT03052777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

January 31, 2017

Last Update Submit

October 2, 2017

Conditions

LeukemiaLymphomaLymphoma, Non-HodgkinBehavior, Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change from baseline in Exercise Motivation

    Baseline and within 7 days of completing the 12-week intervention

  • Change from baseline in Quality of life

    Baseline and within 7 days of completing the 12-week intervention

  • Change from baseline in Fatigue

    Baseline and within 7 days of completing the 12-week intervention

Study Arms (2)

Telephone Counselling

EXPERIMENTAL

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.

Behavioral: Telephone counselling

Control

NO INTERVENTION

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.

Interventions

Telephone counsellingBEHAVIORAL

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.

Telephone Counselling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, t6g 2h9, Canada

Location

Related Publications (2)

  • 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.

    PMID: 30501541DERIVED

  • 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.

    PMID: 29411314DERIVED

MeSH Terms

Conditions

LeukemiaLymphomaLymphoma, Non-HodgkinHealth Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

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
Principal Investigator

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 14, 2017

Study Start

February 21, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)