Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion

Malignant Neoplasm Clinical Trial

Official title:

A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion

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
• 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
• 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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

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