Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
22. juli 2020 oppdatert av: Sheila Ridner, Vanderbilt-Ingram Cancer Center
A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion
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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University School of Nursing
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 17 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Yogaperapi
|
Hjelpestudier
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Modifications
Tidsramme: Up to 2 years
|
Will be assessed qualitatively.
A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others.
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Up to 2 years
|
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Recruitment
Tidsramme: Up to 2 years
|
The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied.
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Up to 2 years
|
|
Retention
Tidsramme: Up to 2 years
|
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
Tidsramme: Up to 2 years
|
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.
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Up to 2 years
|
|
Participant satisfaction
Tidsramme: Up to 2 years
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Child psychological distress
Tidsramme: Up to 2 years
|
Will assess child distress using Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences- Short Form
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Up to 2 years
|
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Depression - Short Form
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Up to 2 years
|
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form
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Up to 2 years
|
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Anxiety
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Up to 2 years
|
|
Child and parent physiological stress
Tidsramme: Up to 2 years
|
Will assess blood pressure
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Up to 2 years
|
|
Child and parent physiological stress
Tidsramme: Up to 2 years
|
Will assess heart rate
|
Up to 2 years
|
|
Child and parent physiological stress
Tidsramme: Up to 2 years
|
Will assess respiratory rate
|
Up to 2 years
|
|
Parent-child communication
Tidsramme: Up to 2 years
|
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
|
|
Child physical symptoms
Tidsramme: Up to 2 years
|
Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form.
|
Up to 2 years
|
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Parent distress will be assessed using the NIH Toolbox Perceived Stress
|
Up to 2 years
|
|
Child psychological distress
Tidsramme: Up to 2 years
|
Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form
|
Up to 2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Terrah Akard, PhD, Vanderbilt University School of Nursing
- Hovedetterforsker: Sheila Ridner, PhD, Vanderbilt University School of Nursing
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. august 2019
Primær fullføring (Faktiske)
29. juni 2020
Studiet fullført (Faktiske)
30. juni 2020
Datoer for studieregistrering
Først innsendt
17. juli 2019
Først innsendt som oppfylte QC-kriteriene
25. juli 2019
Først lagt ut (Faktiske)
26. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VICC SUPP 1935
- NCI-2019-04525 (Registeridentifikator: NCI, Clinical Trials Reporting Program)
Plan for individuelle deltakerdata (IPD)
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NEI
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