Trial Outcomes & Findings for Supportive Care for Patients Newly Diagnosed With Lung Cancer (NCT NCT01883986)

Last Updated: 2017-01-31

Results Overview

Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2017-01-31

Participant Flow

We recruited 41 outpatients with lung cancer of any stage or type at the Puget Sound Health Care System within two months of diagnosis between 3/6/2014 and 9/1/2015. We reviewed weekly tumor board lists and consults to oncology and pulmonary services to mail invitation letters to eligible patients and then follow up by telephone.

Forty-one subjects completed informed consent and forty subjects were randomized. The subject who was consented, but not randomized, became ineligible by enrolling in hospice care.

Participant milestones

Participant milestones
Measure	Intervention This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.	Usual Care Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
Overall Study STARTED	20	20
Overall Study Did Not Complete Study	3	1
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supportive Care for Patients Newly Diagnosed With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.	Usual Care n=20 Participants Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.	Total n=40 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 6 • n=93 Participants	64.9 years STANDARD_DEVIATION 17.6 • n=4 Participants	66.7 years STANDARD_DEVIATION 13.1 • n=27 Participants
Gender Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Gender Male	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.	Usual Care n=20 Participants Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months	2.7 units on a scale Standard Deviation 9.5	4.7 units on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline and 3 months

Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 \> indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.	Usual Care n=20 Participants Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
Change From Baseline in Patient Satisfaction of Care at 3 Months	.76 units on a scale Standard Deviation 9.6	1.02 units on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline and 3 months

The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item "general communication skills" scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.	Usual Care n=20 Participants Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
Change in Baseline Quality of Clinician Communication at 3 Months	-.18 units on a scale Standard Deviation 1.91	.39 units on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: No data was collected due to poor provider response to surveys.

Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn F. Reinke, PhD, ARNP

VA Puget Sound Health Care System

Phone: 206-277-4186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place