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

NCT04034914 | Terminated DMC

• 2 other identifiers: VICC SUPP 1935NCI-2019-04525
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Child psychological distress

  Up to 2 years

• Parent psychological distress

  Up to 2 years

• Parent psychological distress

  Up to 2 years

• Parent psychological distress

  Up to 2 years

• Child and parent physiological stress

  Up to 2 years

Study Arms (1)

Yoga Therapy

EXPERIMENTAL

Other: Questionnaire administration

Interventions

Questionnaire administration OTHER

Ancillary studies

Yoga Therapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sheila Ridner, PhD

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

• Terrah Akard, PhD

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: August 7, 2019
• Primary Completion: June 29, 2020
• Study Completion: June 30, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)