Malignant NeoplasmNCT04034914
Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
A study testing Questionnaire administration in people with Malignant Neoplasm, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University School of Nursing
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Questionnaire administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Yoga Therapy | Experimental | Not described Receives: Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (11)
Child psychological distress
Will assess child distress using Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences- Short Form
Measured: Up to 2 years
Parent psychological distress
Will assess parent distress using the PROMIS Depression - Short Form
Measured: Up to 2 years
Parent psychological distress
Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form
Measured: Up to 2 years
Parent psychological distress
Will assess parent distress using the PROMIS Anxiety
Measured: Up to 2 years
Child and parent physiological stress
Will assess blood pressure
Measured: Up to 2 years
Child and parent physiological stress
Will assess heart rate
Measured: Up to 2 years
Child and parent physiological stress
Will assess respiratory rate
Measured: Up to 2 years
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.
Measured: Up to 2 years
Child physical symptoms
Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form.
Measured: Up to 2 years
Parent psychological distress
Parent distress will be assessed using the NIH Toolbox Perceived Stress
Measured: Up to 2 years
Child psychological distress
Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start7 Aug 2019
- Primary completion29 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt-Ingram Cancer Center
- Investigators
- Sheila Ridner, PhD, Principal investigator, Vanderbilt University School of NursingTerrah Akard, PhD, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034914
- Sponsor's protocol ID
- VICC SUPP 1935
- Other IDs
- NCI-2019-04525
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2019
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion
- ClinicalTrials.gov ID
- NCT04034914
- Acronym / sponsor ID
- VICC SUPP 1935
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Therapy | Experimental | Other: Questionnaire administration |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationAncillary studies | Other | Yoga Therapy |
Primary outcome
Modifications
Time frame: 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.
Recruitment
Time frame: Up to 2 years
The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied.
Retention
Time frame: 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.
Barriers
Time frame: 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.
Participant satisfaction
Time frame: 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.
11 secondary outcomes
Child psychological distress
Time frame: Up to 2 years
Parent psychological distress
Time frame: Up to 2 years
Parent psychological distress
Time frame: Up to 2 years
Parent psychological distress
Time frame: Up to 2 years
Child and parent physiological stress
Time frame: Up to 2 years
Child and parent physiological stress
Time frame: Up to 2 years
Child and parent physiological stress
Time frame: Up to 2 years
Parent-child communication
Time frame: Up to 2 years
Child physical symptoms
Time frame: Up to 2 years
Parent psychological distress
Time frame: Up to 2 years
Child psychological distress
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila Ridner, PhD principal investigator
Vanderbilt University School of Nursing
Terrah Akard, PhD principal investigator
Vanderbilt University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire administration in people with Malignant Neoplasm, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modifications (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.