Trial Outcomes & Findings for Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy (NCT NCT03860961)

NCT ID: NCT03860961

Last Updated: 2025-11-03

Results Overview

A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria: * saw a primary care provider (PCP) or cardiologist * had fasting blood glucose checked * had fasting cholesterol check.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 550 participants
• Primary outcome timeframe: During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.
• Results posted on: 2025-11-03

Participant Flow

Of 833 participants screened at randomized practices, 550 were enrolled.

Unit of analysis: Practices

Participant milestones

Measure	Arm A (Survivorship Care Plan) Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).	Arm B (Enhanced Survivorship Care Plan) Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Overall Study STARTED	277 18	273 17
Overall Study COMPLETED	257 18	256 17
Overall Study NOT COMPLETED	20 0	17 0

Reasons for withdrawal

Measure	Arm A (Survivorship Care Plan) Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).	Arm B (Enhanced Survivorship Care Plan) Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Overall Study Withdrawal by Subject	6	11
Overall Study Death	10	6
Overall Study Incomplete two-year data	4	0

Baseline Characteristics

Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.

Baseline characteristics by cohort

Measure	Arm A (SCP) n=277 Participants Practices review a SCP with patients and send it to the PCP during the last week of RT.	Arm B (Enhanced SCP) n=273 Participants Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.	Total n=550 Participants Total of all reporting groups
Age, Continuous	70 years n=277 Participants	70 years n=273 Participants	70 years n=550 Participants
Age, Customized < 65 years	70 Participants n=277 Participants	61 Participants n=273 Participants	131 Participants n=550 Participants
Age, Customized ≥ 65 years	207 Participants n=277 Participants	212 Participants n=273 Participants	419 Participants n=550 Participants
Sex: Female, Male Female	0 Participants n=277 Participants	0 Participants n=273 Participants	0 Participants n=550 Participants
Sex: Female, Male Male	277 Participants n=277 Participants	273 Participants n=273 Participants	550 Participants n=550 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=277 Participants	7 Participants n=273 Participants	9 Participants n=550 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	268 Participants n=277 Participants	261 Participants n=273 Participants	529 Participants n=550 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=277 Participants	5 Participants n=273 Participants	12 Participants n=550 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=277 Participants	2 Participants n=273 Participants	3 Participants n=550 Participants
Race (NIH/OMB) Asian	2 Participants n=277 Participants	3 Participants n=273 Participants	5 Participants n=550 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=277 Participants	0 Participants n=273 Participants	0 Participants n=550 Participants
Race (NIH/OMB) Black or African American	39 Participants n=277 Participants	42 Participants n=273 Participants	81 Participants n=550 Participants
Race (NIH/OMB) White	229 Participants n=277 Participants	220 Participants n=273 Participants	449 Participants n=550 Participants
Race (NIH/OMB) More than one race	0 Participants n=277 Participants	1 Participants n=273 Participants	1 Participants n=550 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=277 Participants	5 Participants n=273 Participants	11 Participants n=550 Participants
Past smoker	142 Participants n=277 Participants	139 Participants n=273 Participants	281 Participants n=550 Participants
Current smoker	31 Participants n=277 Participants	33 Participants n=273 Participants	64 Participants n=550 Participants
Uses hypertension medication	187 Participants n=277 Participants	179 Participants n=273 Participants	366 Participants n=550 Participants
Has Diabetes	70 Participants n=277 Participants	72 Participants n=273 Participants	142 Participants n=550 Participants
Number of comorbidities determined by the Adult Comorbitity Evaluation-27 (ACE-27) ≤ 2	185 Participants n=277 Participants	181 Participants n=273 Participants	366 Participants n=550 Participants
Number of comorbidities determined by the Adult Comorbitity Evaluation-27 (ACE-27) >2	92 Participants n=277 Participants	92 Participants n=273 Participants	184 Participants n=550 Participants
Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Inadequate	30 Participants n=276 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	35 Participants n=271 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	65 Participants n=547 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.
Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Adequate	201 Participants n=276 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	175 Participants n=271 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	376 Participants n=547 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.
Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Marginal	45 Participants n=276 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	61 Participants n=271 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.	106 Participants n=547 Participants • Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.

PRIMARY outcome

Timeframe: During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.

Population: Eligible participants from randomized practices with necessary data for this outcome measure.

A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria:

• saw a primary care provider (PCP) or cardiologist
• had fasting blood glucose checked
• had fasting cholesterol check.

Outcome measures

Measure	Arm A (Survivorship Care Plan) n=257 Participants Practices review a SCP with patients and send it to the PCP during the last week of RT.	Arm B (Enhanced Survivorship Care Plan) n=256 Participants Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment	160 Participants	157 Participants

SECONDARY outcome

Timeframe: Two years after completion of approximately 4-9 weeks of radiation therapy.

Population: Eligible participants with CVD risk score at two years.

CVD risk score is obtained using the American Heart Association Risk Calculator (Goff et al, 2013). The calculator requires sex (all participants are male in this trial), age, race (White, African American, Other), HDL, total cholesterol, systolic blood pressure, diabetes (yes/no), treatment for hypertension (yes/no), smoker (yes/no), and provides a 10-year risk of atherosclerotic cardiovascular disease (ASCVD) events ranging from 0 (low risk) to 1 (high risk). The calculator documentation states that risk may be overestimated or underestimated for some subgroups of the race category "Other", therefore score is not calculated for any participants in this category.

Outcome measures

Measure	Arm A (Survivorship Care Plan) n=171 Participants Practices review a SCP with patients and send it to the PCP during the last week of RT.	Arm B (Enhanced Survivorship Care Plan) n=161 Participants Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Calculated Cardiovascular (CVD) Risk Score at Two Years	0.257 score on a scale Standard Deviation 0.134	0.256 score on a scale Standard Deviation 0.135

SECONDARY outcome

Timeframe: Two years after completion of approximately 4-9 weeks of radiation therapy.

Population: Eligible participants with two-year CPCI data

The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score.

Outcome measures

Measure	Arm A (Survivorship Care Plan) n=204 Participants Practices review a SCP with patients and send it to the PCP during the last week of RT.	Arm B (Enhanced Survivorship Care Plan) n=193 Participants Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)	5.29 score on a scale Standard Deviation 0.96	5.46 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Two years after completion of approximately 4-9 weeks of radiation therapy.

Population: Eligible participants with two-year Patient Satisfaction with Care questionnaire data.

This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.

Outcome measures

Measure	Arm A (Survivorship Care Plan) n=195 Participants Practices review a SCP with patients and send it to the PCP during the last week of RT.	Arm B (Enhanced Survivorship Care Plan) n=192 Participants Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.
Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)	81.96 score on a scale Standard Deviation 9.18	82.68 score on a scale Standard Deviation 11.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Two years after completion of approximately 4-9 weeks of radiation therapy.

The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Two years after completion of approximately 4-9 weeks of radiation therapy.

This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (SCP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B (Enhanced SCP)

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

Wendy Seiferheld

NRG Oncology

Phone: (215) 574-3208

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER