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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04034914
Other study ID # VICC SUPP 1935
Secondary ID NCI-2019-04525
Status Terminated
Phase N/A
First received
Last updated
Start date August 7, 2019
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion. Pediatric cancer and its treatment is one of life's most stressful events for children and their parents. Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.


Description:

PRIMARY OBJECTIVES:

- To determine the feasibility of Yoga for children with cancer and their parents, specifically

- Identify possible required modifications for safe and feasible practice during infusions.

- Obtain recruitment estimates and determine barriers.

- Assess satisfaction.

SECONDARY OBJECTIVES:

- To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:

- Child psychological distress (stress, anxiety).

- Parent psychological distress (stress, anxiety, anger, depression).

- Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).

- Parent-child communication.

- Child physical symptoms.

OUTLINE:

Patients and parents participate in up to 8 Yoga sessions consisting of check in, awareness, breathing practices, gentle movement, and relaxation over 30 minutes each.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date June 30, 2020
Est. primary completion date June 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria:

- Children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with Monroe Carell Jr. Children's Hospital.

- Parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary).

Children and Parents: able to speak and understand English, absence of cognitive impairment, and willing to engage in Yoga as part of a dyad.

Exclusion Criteria:

- CHILDREN: Medical conditions that would prohibit the safe implementation of a Yoga practice

- PARENTS: Practices Yoga weekly

- PARENTS: Pregnant or plans to become pregnant during next 3 months

- CHILDREN AND PARENTS: Unwilling to work as a dyad.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire administration
Ancillary studies

Locations

Country Name City State
United States Vanderbilt University School of Nursing Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modifications Will be assessed qualitatively. A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others. Up to 2 years
Primary Recruitment The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied. Up to 2 years
Primary Retention The number of the enrolled child-parent dyads who complete both the self-report assessments required at baseline (T1 - prior to first Yoga session), the Yoga protocol, and the measures at the end-of-infusion (T2 - prior to last Yoga session) will be tallied. The proportion completing will be used to inform the level of over-recruitment required in future studies of efficacy. Up to 2 years
Primary Barriers Participants who do not complete the study will be contacted and queried as to the reason for the lack of completion. A tally of the specific barriers will be maintained to determine if particular barriers are encountered more frequently than others. This information will inform possible modifications required to the protocol in future research. Up to 2 years
Primary Participant satisfaction The total number of responses to the 14 satisfaction questions with a rating > 4 (maximum rating = 7) will be generated for each of the 5 parent participants. It is expected that all participants will exceed that threshold for all questions. If not, frequency distributions will be used to summarize the responses to each of the 14 items to assess which produced the lower ratings. Responses to open-ended questions will be analyzed qualitatively. Findings from both components of the satisfaction survey (program satisfaction and yoga survey) will be used to revise the Yoga protocol as needed. Up to 2 years
Secondary Child psychological distress Will assess child distress using Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences- Short Form Up to 2 years
Secondary Parent psychological distress Will assess parent distress using the PROMIS Depression - Short Form Up to 2 years
Secondary Parent psychological distress Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form Up to 2 years
Secondary Parent psychological distress Will assess parent distress using the PROMIS Anxiety Up to 2 years
Secondary Child and parent physiological stress Will assess blood pressure Up to 2 years
Secondary Child and parent physiological stress Will assess heart rate Up to 2 years
Secondary Child and parent physiological stress Will assess respiratory rate Up to 2 years
Secondary Parent-child communication Will be assessed using the Parent-Adolescent Communication Scale (PACS). Participants answer 20-40 questions. A total score is calculated ranging from 20-100 with higher scores indicating more positive communication. Up to 2 years
Secondary Child physical symptoms Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form. Up to 2 years
Secondary Parent psychological distress Parent distress will be assessed using the NIH Toolbox Perceived Stress Up to 2 years
Secondary Child psychological distress Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form Up to 2 years
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