Anxiety DisorderNCT05056831
Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients
A study testing Behavioral Intervention, Best Practice and Informational Intervention in people with Anxiety Disorder and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention, Best Practice and Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Behavioral Intervention, Best Practice, Informational Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Anxiety Disorders, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Attend face-to-face mind-body sessions
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Informational InterventionOther
Receive targeted text messages
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (physical activity intervention) | Experimental | 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. Receives: Behavioral: Behavioral Intervention; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a multicomponent intervention that assesses the perspective of health care provider
Measured: Through study completion, an average of 1 year
To establish a multicomponent intervention that assesses the perspective of cancer survivors
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start21 Jun 2021
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kawut, Steven, MD
- Responsible party
- Sponsor
- Investigators
- Scherezade Mama, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056831
- Sponsor's protocol ID
- 2020-1278
- Other IDs
- NCI-2021-09572, 2020-1278, K07CA222335, R01HL142732
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT05056831
- Acronym / sponsor ID
- 2020-1278
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Request
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kawut, Steven, MD
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (physical activity intervention) | Experimental | Behavioral: Behavioral Intervention, Other: Informational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyAttend face-to-face mind-body sessions | Behavioural | Group I (physical activity intervention) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Group II (usual care) |
| Informational InterventionReceive targeted text messages | Other | Group I (physical activity intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (physical activity intervention), Group II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (physical activity intervention), Group II (usual care) |
Primary outcome
To establish a multicomponent intervention that assesses the perspective of health care provider
Time frame: Through study completion, an average of 1 year
To establish a multicomponent intervention that assesses the perspective of cancer survivors
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: PI Request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scherezade Mama, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Best Practice and Informational Intervention in people with Anxiety Disorder and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a multicomponent intervention that assesses the perspective of health care provider (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.