- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04034914
Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
22. juli 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University School of Nursing
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 17 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Yoga Therapy
|
Hjælpestudier
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
Up to 2 years
|
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.
|
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.
|
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 |
Foranstaltningsbeskrivelse |
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
|
Up to 2 years
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Depression - Short Form
|
Up to 2 years
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form
|
Up to 2 years
|
Parent psychological distress
Tidsramme: Up to 2 years
|
Will assess parent distress using the PROMIS Anxiety
|
Up to 2 years
|
Child and parent physiological stress
Tidsramme: Up to 2 years
|
Will assess blood pressure
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Terrah Akard, PhD, Vanderbilt University School of Nursing
- Ledende efterforsker: Sheila Ridner, PhD, Vanderbilt University School of Nursing
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. august 2019
Primær færdiggørelse (Faktiske)
29. juni 2020
Studieafslutning (Faktiske)
30. juni 2020
Datoer for studieregistrering
Først indsendt
17. juli 2019
Først indsendt, der opfyldte QC-kriterier
25. juli 2019
Først opslået (Faktiske)
26. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VICC SUPP 1935
- NCI-2019-04525 (Registry Identifier: NCI, Clinical Trials Reporting Program)
Plan for individuelle deltagerdata (IPD)
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