Advanced CancerNCT01901237
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
A study testing Hatha Yoga in people with Advanced Cancer, run by Rob Rutledge at 1 site in Canada.
Trial summary
Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Hatha Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to 13 Jun 2017
- 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 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with a non-curative cancer and assigned to non-curative or palliative care
- Between 15-39 years of age
- Have primary physician/oncologist consent to participate
Who cannot join
- Experience any medical conditions that contraindicate yoga (e.g., bone metastases)
- Exhibit cognitive limitations (e.g., psychiatric disorders)
- Score below 30% on Palliative Performance Status Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study
Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.
- Conditions
- Advanced Cancer
- Being tested
- Hatha Yoga
- Keywords
- Cancer, Adolescent and Young Adult, Exercise, Physical Activity, Quality of Life, End-of-Life, Palliative, Terminal, Yoga, Alternative Therapies, Fitness, Fatigue
- Medical subject headings
- Neoplasms, Motor Activity, Death, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha YogaBehavioural
This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga Program | Other | Single-arm pilot study of a 7-week home/hospice-based Hatha yoga program for adolescent and young adults with non-curative cancer. Receives: Behavioral: Hatha Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
Recruitment will be calculated by the number of patients who consent to participate, divided by the number of eligible participants recommended by the primary oncologist/physician.
Measured: Final: end of week 7
Feasibility: Retention
Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing.
Measured: Final: end of week 7
Feasibility: Adherence
Adherence: Participants will be asked to record the number of yoga sessions performed each week. Overall adherence will be calculated by summing the actual number of sessions the participant engaged in, divided by the recommended number of sessions.
Measured: Final: end of week 7
Safety
Safety: Any adverse events reported by the participant will be recorded.
Measured: Final: end of week 7
Secondary outcomes (1)
Changes in Quality of Life
Participants will be asked to complete the Functional Assessment of Chronic Illness Therapy - Palliative Care subscale (FACIT-Pal) and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being subscale (FACIT-Sp) at baseline and post-intervention.
Measured: Baseline: week 1; Final: week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startSep 2013
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Rutledge
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, IWK Health Centre, Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Rob Rutledge, Nova Scotia Health Authority
- Investigators
- Rob Rutledge, MD, FRCPC, Principal investigator, Capital District Health Authority, Halifax, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901237
- Sponsor's protocol ID
- CDHA-RS/2014-067
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2013
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT01901237
- Acronym / sponsor ID
- CDHA-RS/2014-067
- Conditions
- Advanced Cancer
- Keywords
- Cancer, Adolescent and Young Adult, Exercise, Physical Activity, Quality of Life, End-of-Life, Palliative, Terminal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rob RutledgeUniversity, hospital or other
- Collaborators
- Dalhousie University, IWK Health Centre, Nova Scotia Health Authority
- Study start
- Sep 2013
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 17 Jul 2013 (estimated)
- 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.
Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga Program | Other | Behavioral: Hatha YogaSingle-arm pilot study of a 7-week home/hospice-based Hatha yoga program for adolescent and young adults with non-curative cancer. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with a non-curative cancer and assigned to non-curative or palliative care
- Between 15-39 years of age
- Have primary physician/oncologist consent to participate
Key exclusion criteria (3 listed)
- Experience any medical conditions that contraindicate yoga (e.g., bone metastases)
- Exhibit cognitive limitations (e.g., psychiatric disorders)
- Score below 30% on Palliative Performance Status Scale
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 |
|---|---|---|
| Hatha YogaThis is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period. | Behavioural | Hatha Yoga Program |
Primary outcome
Feasibility: Recruitment
Time frame: Final: end of week 7
Recruitment will be calculated by the number of patients who consent to participate, divided by the number of eligible participants recommended by the primary oncologist/physician.
Feasibility: Retention
Time frame: Final: end of week 7
Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing.
Feasibility: Adherence
Time frame: Final: end of week 7
Adherence: Participants will be asked to record the number of yoga sessions performed each week. Overall adherence will be calculated by summing the actual number of sessions the participant engaged in, divided by the recommended number of sessions.
Safety
Time frame: Final: end of week 7
Safety: Any adverse events reported by the participant will be recorded.
1 secondary outcome
Changes in Quality of Life
Time frame: Baseline: week 1; Final: week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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.
Rob Rutledge, MD, FRCPC principal investigator
Capital District Health Authority, Halifax, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga in people with Advanced Cancer, run by Rob Rutledge at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 13 Jul 2017. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Recruitment (time frame: Final: end of week 7). The study lists 4 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 13 Jul 2017.