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A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units ; A multi-center randomized controlled trial

A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units ; A multi-center randomized controlled trial - A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units ; A multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037298
Enrollment
135
Registered
2019-07-07
Start date
2019-07-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

specialized rehabilitation following the Op-reha guide provided by rehabilitation therapist (Op-reha group) usual rehabilitation provided by specialized rehabilitation therapist (Usual rehab group) U

Sponsors

Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Hospitalized in PCU (only initial hospitalization of PCU) 2) Patients who are 20 years old or more at the time of the informed consent. 3) Clinical cancer diagnosis 4) No treatment with curative intent(treatment is surgery, chemotherapy and Radiation therapy) 5) Eastern Cooperative Oncology Group Performance Status= 2-3 6) Life expectancy to be 3 weeks or more (Palliative Prognostic Index or less 6) 7) Starting rehabilitation within 1 week after hospitalization of PCU (RCT group) 8) Patients who agree to participate in the study with the written informed consent

Exclusion criteria

Exclusion criteria: 1) Severe symptom burden (any of STAS 3 items (Pain control/Other symptom control/Patient anxiety) = score 4) 2) Respite admission (admission term is about within 1-2 weeks) 3) Road limited due to impending bone fractur 4)Nerve block anesthesia or Percutaneous vertebroplasty (cement composition) 5) The physicians or rehabilitation therapists in charge judge it difficult for their patients to participate in the program

Design outcomes

Primary

MeasureTime frame
Change in total score of modified Barthel Index (mBI)from baseline after 3 weeks

Secondary

MeasureTime frame
1) Change in total score of mBI from baseline after 2 weeks/ 1 week 2)Change in each sub item score of mBI from baseline after 3 weeks/ 2 weeks/ 1 week 3) Longitudinal change in total and each sub item score of mBI in baseline, after 1 week, after 2 weeks and after 3 weeks 4) Proportion of patients who declined 10 points or more in total score of mBI from baseline after 1 week/ 2 weeks/ 3 weeks 5) Change in each domain score of EORTC QLQ-C15-PAL from baseline after 3 weeks/ 2 weeks/ 1 week 6) Adverse events

Countries

Japan

Contacts

Public ContactNanako Nishiyama

Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC) Department of Clinical research

nishiyama-nnk@umin.org03-5604-9850

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026