Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607590
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2020-05-20
Brief Title:
Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Yoga Program for Couples Coping With Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial seeks to learn if a yoga program can improve physical performance quality of life and symptom burden in cancer patients who are undergoing radiation therapy and their partners Taking part in yoga or stretching sessions may lower distress improve quality of life andor may improve sleep and fatigue for cancer patients and their caregivers
Detailed Description:
PRIMARY OBJECTIVE
I To examine the extent to which the dyadic yoga DY program improves patient objective physical performance as compared to the waitlist control WLC group primary comparison and the patient-only yoga PY group exploratory comparison
SECONDARY OBJECTIVE
I To examine the extent to which the DY program improves patient and partner quality of life QOL compared to the WLC group primary comparison and the PY group exploratory comparison
TERTIARY OBJECTIVE
I To examine the extent to which the DY program reduces patient healthcare utilization ie emergency room visits hospital admissions and feeding tube insertions and patient and partner work productivity compared to the WLC group primary comparison and the PY group exploratory comparison
EXPLORATORY OBJECTIVE
I To explore if compared to the WLC and PY groups the DY program improves symptom burden and symptom management skills at the end of treatment which will in turn mediate intervention outcomes at the subsequent follow-up assessments
OUTLINE Patients are randomized to 1 of 3 groups
GROUP I DY Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions lasting 60 minutes each in-person or via videoconferencing over the course of radiation therapy
GROUP II PY Patients attend yoga sessions 3 days per week for up to 15 sessions lasting 60 minutes each in-person or via videoconferencing over the course of radiation therapy Once data collection is completed partners are offered intervention materials and encouraged to attend yoga classes at the Integrative Medicine Clinic
GROUP III WLC Patients and their partner receive usual care Once data collection is completed couples may participate in the DY or PY program of their choice over 60 minutes each Partners are also offered intervention materials along with five 60 minute optional yoga sessions
After completion of radiation therapy patients are followed up at 1 2 3 and 6 months
I To examine the extent to which the dyadic yoga DY program improves patient objective physical performance as compared to the waitlist control WLC group primary comparison and the patient-only yoga PY group exploratory comparison
SECONDARY OBJECTIVE
I To examine the extent to which the DY program improves patient and partner quality of life QOL compared to the WLC group primary comparison and the PY group exploratory comparison
TERTIARY OBJECTIVE
I To examine the extent to which the DY program reduces patient healthcare utilization ie emergency room visits hospital admissions and feeding tube insertions and patient and partner work productivity compared to the WLC group primary comparison and the PY group exploratory comparison
EXPLORATORY OBJECTIVE
I To explore if compared to the WLC and PY groups the DY program improves symptom burden and symptom management skills at the end of treatment which will in turn mediate intervention outcomes at the subsequent follow-up assessments
OUTLINE Patients are randomized to 1 of 3 groups
GROUP I DY Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions lasting 60 minutes each in-person or via videoconferencing over the course of radiation therapy
GROUP II PY Patients attend yoga sessions 3 days per week for up to 15 sessions lasting 60 minutes each in-person or via videoconferencing over the course of radiation therapy Once data collection is completed partners are offered intervention materials and encouraged to attend yoga classes at the Integrative Medicine Clinic
GROUP III WLC Patients and their partner receive usual care Once data collection is completed couples may participate in the DY or PY program of their choice over 60 minutes each Partners are also offered intervention materials along with five 60 minute optional yoga sessions
After completion of radiation therapy patients are followed up at 1 2 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-0887 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-02943 | REGISTRY | None | None |