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Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients

Primary Purpose

Anxiety Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Best Practice
Informational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PROVIDERS: Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators)
  • PROVIDERS: Place of engagement falls within a rural county in Texas
  • PROVIDERS: Able to read, speak, and write in English
  • PROVIDERS: At least 18 years old
  • PROVIDERS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
  • INTERVIEW SURVIVORS: Men and women >= 18 years of age
  • INTERVIEW SURVIVORS: History of cancer
  • INTERVIEW SURVIVORS: Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (=< 1 year)
  • INTERVIEW SURVIVORS: Able to read, speak, and write in English
  • INTERVIEW SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
  • INTERVENTION SURVIVORS: Men and women >= 18 years of age
  • INTERVENTION SURVIVORS: Received a solid tumor cancer diagnosis stage I-III
  • INTERVENTION SURVIVORS: Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks
  • INTERVENTION SURVIVORS: Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner)
  • INTERVENTION SURVIVORS: Physician clearance to participate in the study
  • INTERVENTION SURVIVORS: Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)
  • INTERVENTION SURVIVORS: Live within MD Anderson's rural catchment area
  • INTERVENTION SURVIVORS: Have a home address where information can be mailed and a working telephone
  • INTERVENTION SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
  • INTERVENTION SURVIVORS: Able to read, speak, and write in English
  • INTERVENTION SURVIVORS: Able to receive text messages on their smartphone (via cellular data or wireless internet)

Exclusion Criteria:

  • PROVIDERS: Does not work with cancer survivors
  • PROVIDERS: Place of work or engagement falls within an urban/metropolitan county in Texas
  • PROVIDERS: Does not read, speak, or write in English
  • PROVIDERS: Below the age of 18 years
  • INTERVIEW SURVIVORS: No history of cancer
  • INTERVIEW SURVIVORS: Does not read, speak, or write in English
  • INTERVIEW SURVIVORS: Below the age of 18
  • INTERVENTION SURVIVORS: No history of cancer
  • INTERVENTION SURVIVORS: Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)
  • INTERVENTION SURVIVORS: Currently participating in another intervention to increase physical activity or reduce sedentary behavior
  • INTERVENTION SURVIVORS: Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)
  • INTERVENTION SURVIVORS: Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the Physical Activity Readiness Questionnaire (PAR-Q), and any physical limitation that prevents engaging in moderate intensity exercise
  • INTERVENTION SURVIVORS: Primary address falls within an urban/metropolitan county in Texas
  • INTERVENTION SURVIVORS: Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period
  • INTERVETION SURVIVORS: Does not read, speak, or write in English
  • INTERVENTION SURVIVORS: Below the age of 18
  • INTERVENTION SURVIVORS: Pregnant or planning to become pregnant during the 14 week study period

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (physical activity intervention)

Group II (usual care)

Arm Description

Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.

Patients receive usual care.

Outcomes

Primary Outcome Measures

To establish a multicomponent intervention that assesses the perspective of health care provider
To establish a multicomponent intervention that assesses the perspective of cancer survivors

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
September 7, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05056831
Brief Title
Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients
Official Title
Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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

5. Study Description

Brief Summary
This study adapts and assesses the effect of a multicomponent physical activity intervention in reducing psychosocial distress in cancer patients. This study aims to develop a program to help increase physical activity and reduce stress in cancer survivors who live in rural areas.
Detailed Description
PRIMARY OBJECTIVES: I. To adapt a multicomponent intervention (HH+AIM) that assesses the perspective of health care provider and cancer survivors about: Ia. Needs related to psychosocial distress and health behaviors in rural patients with cancer. Ib. Needs related to implementing interventions within the treatment setting. Ic. Barriers to intervention delivery/participate. Id. Preferred means/methods for referring participants and receiving information related to the intervention. SECONDARY OBJECTIVES: I. To assess time spent sitting in prolonged bouts of 20 consecutive minutes or more (minutes/day). II. To assess daily number of steps (collected using the activPAL over 7 days at week 8, data will be averaging over 7 days to get minutes per day). III. To assess psychosocial distress measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores. IV. To assess health-related quality of life measured using the SF-36 short form. OUTLINE: PART I: Patients and providers complete a questionnaire and attend an interview over 1 hour. PART II: Patients are randomized to 1 of 2 groups. GROUP I: Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks. GROUP II: Patients receive usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group I (physical activity intervention)
Arm Type
Experimental
Arm Description
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
Arm Title
Group II (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Attend face-to-face mind-body sessions
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive targeted text messages
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
To establish a multicomponent intervention that assesses the perspective of health care provider
Time Frame
Through study completion, an average of 1 year
Title
To establish a multicomponent intervention that assesses the perspective of cancer survivors
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PROVIDERS: Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators) PROVIDERS: Place of engagement falls within a rural county in Texas PROVIDERS: Able to read, speak, and write in English PROVIDERS: At least 18 years old PROVIDERS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions INTERVIEW SURVIVORS: Men and women >= 18 years of age INTERVIEW SURVIVORS: History of cancer INTERVIEW SURVIVORS: Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (=< 1 year) INTERVIEW SURVIVORS: Able to read, speak, and write in English INTERVIEW SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions INTERVENTION SURVIVORS: Men and women >= 18 years of age INTERVENTION SURVIVORS: Received a solid tumor cancer diagnosis stage I-III INTERVENTION SURVIVORS: Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks INTERVENTION SURVIVORS: Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) INTERVENTION SURVIVORS: Physician clearance to participate in the study INTERVENTION SURVIVORS: Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months) INTERVENTION SURVIVORS: Live within MD Anderson's rural catchment area INTERVENTION SURVIVORS: Have a home address where information can be mailed and a working telephone INTERVENTION SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions INTERVENTION SURVIVORS: Able to read, speak, and write in English INTERVENTION SURVIVORS: Able to receive text messages on their smartphone (via cellular data or wireless internet) Exclusion Criteria: PROVIDERS: Does not work with cancer survivors PROVIDERS: Place of work or engagement falls within an urban/metropolitan county in Texas PROVIDERS: Does not read, speak, or write in English PROVIDERS: Below the age of 18 years INTERVIEW SURVIVORS: No history of cancer INTERVIEW SURVIVORS: Does not read, speak, or write in English INTERVIEW SURVIVORS: Below the age of 18 INTERVENTION SURVIVORS: No history of cancer INTERVENTION SURVIVORS: Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations) INTERVENTION SURVIVORS: Currently participating in another intervention to increase physical activity or reduce sedentary behavior INTERVENTION SURVIVORS: Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months) INTERVENTION SURVIVORS: Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the Physical Activity Readiness Questionnaire (PAR-Q), and any physical limitation that prevents engaging in moderate intensity exercise INTERVENTION SURVIVORS: Primary address falls within an urban/metropolitan county in Texas INTERVENTION SURVIVORS: Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period INTERVETION SURVIVORS: Does not read, speak, or write in English INTERVENTION SURVIVORS: Below the age of 18 INTERVENTION SURVIVORS: Pregnant or planning to become pregnant during the 14 week study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scherezade Mama, MD
Phone
(713) 563-7546
Email
SKMama@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scherezade Mama, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scherezade Mama, MD
Phone
713-563-7546
Email
skmama@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Scherezade Mama, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients

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