Early Palliative Rehabilitation Improves QOL in Advanced Cancer

November 21, 2018

SAN DIEGO — In what is thought to be the first randomized trial to test early palliative rehabilitation, which was initiated soon after a cancer diagnosis and integrated into standard oncology care, the intervention was shown to improve quality of life.

In another first, the authors used an individualized outcome measure that tested a highly flexible intervention model in which patients themselves selected the issues they felt were most important.

"We found that early palliative rehabilitation was better than standard oncology care in helping the patients with the problems they prioritize," said lead author Lise Nottelmann, MD, from the University of Southern Denmark, Odense.

The findings were presented here at the 2018 Palliative and Supportive Care in Oncology Symposium.

Nottelmann noted that while palliative care and rehabilitation can both improve the quality of life in cancer patients, research on their combination and early integration into oncology care is very limited.

"So this led to the underlying question of the study — can a 12-week palliative rehabilitation program that is begun soon after an advanced cancer diagnosis and integrated into standard oncology care improve quality of life?" she said. "Our study tried to answer that question."

Primary Outcome Met

The trial involved 301 patients with various cancers, including lung (40%), gastrointestinal (27%), prostate (18%), and other types of non-resectable solid tumors (15%). They were randomly assigned to the intervention group (n = 139) or standard care (n = 149). All participants had been diagnosed within the past 8 weeks.

The intervention group consisted of standard care with the additional "offer" of individually tailored palliative rehabilitation. At baseline, participants were asked to choose what they specifically felt they needed help with the most from a list of possible "primary problems" corresponding to 12 of the 15 EORTC QLQ-C30 scales. The items that patients could choose from included: physical function, role function, cognitive function, social function, fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, and constipation. They could also choose none of the above; in that case, they were measured on overall quality of life.

"In the rehabilitation group, patients had a consultation with a specialized palliative care physician and nurse, and a 12-week possibility of contacting a palliative rehabilitation team if needed," explained Nottelmann. "Midway through the study, there was a follow-up consultation with a specialized palliative care nurse."

Possible supplementary elements of the palliative rehabilitation intervention program included a group program with patient and caregiver in combination with physical exercise and/or individual consultations as needed.

The participants were assessed at baseline and after 6 and 12 weeks with an extended version of the EORTC QLQ-C30 questionnaire using the item banks for computer-adaptive testing to obtain improved measurement. The study's primary outcome was the change in that "primary problem" scale measured as the area under the curve across the 12 weeks.

All patients received the initial consultation, while 20% received no more than two consultations, and 45% also participated in the group program (with or without supplementary individual contacts). In addition, 35% received supplementary individual consultations without participating in the group program.

Results showed that for the primary outcome, there was an absolute between-group difference of 3.0 (P = .047). This was confirmed by a sensitivity analysis of the change from baseline to 12 weeks that demonstrated an absolute difference of 3.3 (P = .005).

The change from baseline to 6 weeks was also significant with an absolute difference between groups of 1.3 (P = .234).

"What we also found was that this result was mirrored in the fact that at 12 weeks, 59% of patients in the palliative rehabilitation group agreed that they had received help with their primary problem as compared to 41% in the standard care group," said Nottelmann.

Important Contributions

In a discussion of the paper, Karen Michelle Mustian, PhD, MPH, from the University of Rochester Medical Center in New York, noted that this paper offered several significant contributions to the field of palliative care.

"This is the first randomized study that I am aware of to test early palliative care rehabilitation," she said. "Instead of waiting for a patient to be closer to the end of life, palliative care was initiated as soon as the patient received an advanced cancer diagnosis."

Second, this is also the first randomized trial to test this type of palliative care on a patient-identified outcome, Mustian emphasized. "Rather than picking an outcome that a clinician or that a group of scientists think is important, the patient was asked to identify what is most important to you and what do you need the most help in managing," she said. "They looked at how this program could help with that and that is a pretty high bar to meet."

It is also the first randomized controlled trial to merge palliative care and cancer rehabilitation in this fashion. "And what I found really striking was that 45% — almost half — chose to participate in the program and undergo physical exercise and activity," she added.

The study was funded by the Danish Cancer Society, the Research Council of Lillebaelt Hospital, the Andreas and Grethe Gullev Hansen Foundation, and the Hede Nielsen Foundation. Nottelmann and Mustian had no disclosures.

2018 Palliative and Supportive Care in Oncology Symposium in San Diego, California, Abstract 75. Presented November 17, 2018.

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